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Live Blogging FDA in the 21st Century Conference, Panel 9 – Addressing the Challenges of and Harnessing New Technologies

Last but not least! Our final conference panel focused on “Addressing the Challenges of and Harnessing New Technologies,” and was moderated by Fran Miller.

We heard first from Margaret Riley on “Twenty-First Century Technology with Twentieth Century Baggage: FDA Regulation of Regenerative Medicine.” Riley explained that regenerative medicine (i.e., the use of pluripotent stem cells) has the potential to cure disease, injury, and even remedy organ shortages. Of course, it is a hugely political issue and the debate is emotional, value-laden, and not necessarily logical. As a result, the legislation/regulation that results in this area may be far from ideal.

Focusing on FDA specifically, Riley explained that the agency’s approach to stem cell regulation is rooted in its regulation of gene therapy and tissue products, as initiated in the 1990s. FDA’s regulation of autologous stem cell therapies – in which a person’s own cells are removed, manipulated, and reintroduced – as a drug was recently upheld by the District Court of DC (US v. Regenerative Sciences, 878 F. Supp. 2d 248 (DDC 2012)), but is now on appeal to the DC Circuit. Riley is not sure what the outcome will be on appeal, but noted that getting BLA’s approved on a doctor-by-doctor basis will be very difficult and likely impossible. One possible outcome of FDA regulation is likely to be off-shoring and stem cell tourism; ironically, strict regulation may end up not protecting patients, who will end up going abroad.

Next up was Nathan Cortez, who asked “Is the FDA Equipped to Regulate Mobile Health Devices?”

He began with an introduction to medical apps using iStethoscope as an example, demonstrating the possibility for worrisome self-diagnosis with very little expertise/information. He then gave a variety of other examples, including Airstrip Patient Monitoring (which allows doctors to track patients in real time by tracking multiple hospital monitors); Airstrip OB (which similarly permits a doctor to track fetal and maternal vital signs remotely); Mobile MIM, the very first app cleared through the 510k process, and which raised some concerns at FDA about doctors trying to diagnose patients on a small screen with limited visibility; blood glucose monitoring; and cardiac event monitors.

Cortez explained that not all mobile health apps concern FDA. Those that duplicate textbooks or reference sources, track health and wellness (like calorie counters, etc.), or that help you look up billing codes are not regulated by the agency. FDA did issue a draft guidance on Mobile Medical Applications in 2011, explaining its jurisdiction and areas in which it would apply its enforcement discretion. The agency also issued a final regulation in 2011, 21 CFR 880.6310, which only addressed a small subset of device software that stores data, i.e., the least risky type.

Cortez concluded with his ultimate concern. In response to the question: “Are these apps really dangerous?” he explained that yes, software can be dangerous when it causes hardware to malfunction, or leads to other problematic medical decisions.

The panel concluded with a presentation by David Rosenberg, proposing “A New Regulatory Function for E-Prescriptions: Linking FDA to Physicians and Patient Records.”

Rosenberg suggested that FDA sponsor the use of e-prescriptions as a hub to collect and transfer the wealth of information generated in the practice of medicine. The basic idea is that when a physician is deciding what to do for a given patient, he or she would open an e-prescription that would link directly to FDA and provide the doctor with current warnings, contraindications and the like. The doctor’s prescription decision would then be communicated to an FDA database, pharmacy, insurance company, and others, and the e-prescription would remain open until the doctor supplied information on the patient’s ultimate outcome. The data generated could be used by FDA, other agencies, health researchers, manufacturers, and others to identify trends. This would tremendously help with the review of real-time data, as well as retrospective analysis, and the data could be generalized to a national level or made more specific, to particular hospitals and prescribers to evaluate outcomes.

Rosenberg offered the following schematic of his suggested approach, drawing an analogy to TurboTax:

He emphasized that the system would be admonitory, and the claim for compliance would be that generating the data is in the public’s interest.

During the Q&A, Cortez explained the potential power of mobile health apps to improve medical care in the developing world. He doubts that FDA will do much beyond the 2011 guidance, but emphasized that while these apps can demystify and democratize medicine, it is essential to make sure they can do what they claim.

Rosenberg was asked about the potential liability concerns that may arise with his e-prescribing model, to which he responded that if the system could be used to generate liability, doctors would surely object – but that other approaches are possible. He also explained that implementation of his proposal would need financing, resolution of proprietary issues, and buy-in as a public good. Further, Rosenberg liked the suggestion for some of the e-prescription data and warnings to go directly to patients, and also to possibly generate data regarding the behavior of physicians with industry ties.

Riley was asked about the possibility of regulating autologous stem cell transplants like pharmacy compounding, which she agreed was a potentially helpful approach. She emphasized again that requiring physicians to go through the BLA process individually will make them stop offering this therapy or push them abroad. She also mentioned the possibility of regulating stem cells like assisted reproductive technologies – i.e., not at all and leaving it to the practice of medicine – which she thought was inadvisable.

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We had a tremendously informative and thought-provoking conference. Thanks to all of you who joined us. Video to be posted on the Petrie-Flom Center’s website soon!

About Holly Fernandez Lynch

Holly Fernandez Lynch is co-founder of Bill of Health. She was executive director of the Petrie-Flom Center at Harvard Law School from June 2012 through July 2017. She joined the Department of Medical Ethics and Health Policy at the University of Pennsylvania's Perelman School of Medicine as Assistant Professor and Assistant Faculty Director of Online Education in Fall 2017.